510(k) K983399 ยท MHI Giardia Spp.
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
| Applicant | Genzyme Diagnostics, Cambridge MA, US |
| Decision | Substantially Equivalent, Jan 11, 1999 |
| Received | Sep 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2025 | MEDLINE INDUSTRIES, LP - Northfield Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830 Open, Classified |
MHI | None listed |
| Jul 20, 2004 | Genzyme Diagnostics Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits.
These are sold under two names as follows:
Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac G Terminated |
MHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.